Overview As Principal Quality Engineer at Olympus, you lead product quality across the full lifecycle, ensuring regulatory compliance and driving continuous improvement. You act as the primary quality partner across R&D, Manufacturing, Regulatory, Supply Chain, and Post-Market teams to identify and resolve issues with impact on multiple products. You own CAPA, MRB, risk management, and design transfer, shaping robust processes and evidence-based decisions. The role combines hands-on problem solving with leadership to safeguard patient safety and product quality. You will work in a collaborative, data-driven environment with a clear impact on patient care and device reliability.
Compensation / Benefits- Competitive salaries
- Annual bonus
- 401(k) with company match
- Medical, dental, vision coverage
- Paid vacation and holidays
- Parental leave and adoption assistance
Responsibilities- Serve as the division's key partner for end-to-end product quality
- Escalation point for quality issues, metrics, and risk management
- Lead CAPA processes and validate effectiveness across issues from customers, products, and suppliers
- Support MRB investigations and disposition of nonconforming materials
- Facilitate cross-functional execution of process controls, PFMEAs, control plans, and work instructions
- Oversee design transfer plans and validation activities to ensure regulatory compliance
- Develop and monitor quality metrics and present performance and risk to leadership
Key requirements- Bachelor's degree in Engineering or related technical field
- 10+ years in medical device quality or regulated environment
- Experience with design transfer, process validation, CAPA systems, and investigations
- Proven leadership of cross-functional problem-solving teams
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971
- Strong analytical and statistical data analysis skills
- Excellent root cause and structured problem-solving abilities
- Strong written and verbal communication; ability to influence without authority
- Willingness to travel regionally and internationally
- Cross-functional collaboration
- Effective communication
- Influence without authority
- CAPA systems
- 8D and DMAIC problem-solving
- Risk management (ISO 14971)
